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α-Amylase （α-AMY）Assay Kit (EPS Substrate Method)
EUDAMEDClass IVD General (EU MDR)
Ref R1: 2×60 mL, R2: 2×15 mL
Identity
- Device Name
- α-Amylase （α-AMY）Assay Kit (EPS Substrate Method) EUDAMED
- Model / Reference
- R1: 2×60 mL, R2: 2×15 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974760129773 EUDAMED
- Basic UDI-DI
- B-06974760129773 EUDAMED
- EMDN Code
- W01010107 AMYLASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
α-Amylase （α-AMY）Assay Kit (EPS Substrate Method) by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974760129773 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 1206963c-5f9b-4916-80cb-e139fc0eacc8 61 fields · synced Jun 18, 2026
- EUDAMED 1206963c-5f9b-4916-80cb-e139fc0eacc8-1 61 fields · synced Jun 10, 2026